Deployment actuation system for intrafallopian contraception

ABSTRACT

Contraceptive methods, systems, and devices generally improve the ease, speed, and reliability with which a contraceptive device can be deployed transcervically into an ostium of a fallopian tube. The contraceptive device may remain in a small profile configuration while a sheath is withdrawn proximally, and is thereafter expanded to a large profile configuration engaging the surrounding tissues, by manipulating one or more actuators of a proximal handle with a single hand. This leaves the other hand free to manipulate a hysteroscope, minimizing the number of health care professional required to deploy the contraceptive device.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation application which claims the benefitof priority of U.S. patent application Ser. No. 09/644,287 (AttorneyDocket No. 016355-003910US), filed on Aug. 22, 2000, which claims thebenefit of priority from U.S. Patent Application Ser. No. 60/150,238filed on Aug. 23, 1999, and is related to application U.S. patentapplication Ser. No. 09/644,277, (Attorney Docket No. 16355-003810),entitled “Insertion/Deployment Catheter System for IntrafallopianContraception”, which was filed concurrently therewith, the fulldisclosures of all of these incorporated herein by reference.

STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSOREDRESEARCH OR DEVELOPMENT

Not Applicable

REFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAMLISTING APPENDIX SUBMITTED ON A COMPACT DISK

Not Applicable

BACKGROUND OF THE INVENTION

The present invention generally relates to medical devices, systems, andmethods. In a particular embodiment, the invention provides temporary orpermanent intrafallopian contraceptive devices, delivery systems, andnon-surgical methods for their deployment.

While the theoretical effectiveness of existing non-surgicalcontraceptive techniques, including barrier methods and hormonaltherapies, is well established, the actual effectiveness of most knownmethods is disappointing. One reason for these disappointing results isthat many of the presently available methods for inhibiting pregnancywithout surgery depend upon significant user involvement. Non-compliancetypically results in quite high rates of failure, and overcoming usernon-compliance to improve overall efficacy has proven quite difficult.

One form of long term contraception which is less susceptible to usernon-compliance is the intrauterine device (IUD). IUDs have been found tohave higher rates of reliability, and are effective for a longer periodof time, then most other commercially available contraceptives.Unfortunately, IUDs are also associated with serious infectiouscomplications. For this reason, the use of IUDs within the United Stateshas decreased dramatically. Additionally, IUDs are subject to unplannedexpulsion, and are removed due to excessive pain or bleeding in asignificant percentage of cases, further reducing acceptance of the IUDas a method of inhibiting pregnancy.

Commercially available options for permanent sterilization includefallopian tube ligation and vasectomy. These methods are surgical andare not available to many people in the world. It is common knowledgethat fertilization occurs in the fallopian tubes where the sperm andovum meet. Tubal ligation avoids this by surgical and complete occlusionof the fallopian tubes.

In work done in connection with the present invention, it has previouslybeen proposed to transcervically introduce a resilient coil into afallopian tube so as to inhibit conception. PCT Patent Application No.99/15116, assigned to the present assignee (the full disclosure of whichis incorporated herein by reference) describes devices which aretranscervically inserted into a tubal ostium and mechanically anchoredwithin the fallopian tube. The described devices may promote a tissueingrowth network to provide long term conception and/or permanentsterilization without the need for surgical procedures, and should avoidthe risks of increased bleeding, pain, and infection associated withintrauterine devices.

While the recently proposed intrafallopian contraceptive devicesrepresent a significant advancement in the art, still furtherimprovements would be desirable. In general, it would be desirable toprovide improved non-surgical devices, systems, and methods forinhibiting pregnancy. It would be beneficial if these improvedtechniques increased the ease, speed, and reliability with which thesecontraceptive devices could be deployed. It would be further beneficialif these improved access and deployment techniques could safely andeffectively be performed without numerous assistants, and if they didnot require expensive medical equipment so that they could beimplemented by health care professionals in an outpatient clinic. Someor all of these advantages are provided by the device describedhereinbelow.

SUMMARY OF THE INVENTION

The present invention generally provides improved medical devices,systems, and methods. The techniques of the present invention areparticularly useful for improving the ease, speed, and reliability withwhich contraceptive devices can be deployed transcervically into anostium of a fallopian tube. The invention generally providesintrafallopian contraceptive systems having a handle adapted formanipulation and actuation by a single hand of a healthcare provider.Typically, the handle includes at least one actuator which can bemanipulated by the same hand used to grip the handle. In manyembodiments, the healthcare provider can advance the contraceptivedevice into an ostium of a fallopian tube by manipulating the handle,can withdraw a sheath from around the contraceptive device, can expandthe contraceptive device from a small profile configuration to a largeprofile configuration, and/or can detach the expanded contraceptivedevice from the remaining components of the contraceptive system,ideally all with one hand. Advantageously, this leaves the other handfree to grasp and manipulate a hysteroscope, allowing the healthcareprovider to orient the system toward the tubal ostium and effect itsdeployment while optically viewing and verifying the deployment, ratherthan relying on coordinating the efforts of two separate individuals toaccess the target site and deploy the contraceptive device. Deploymentmay, alternatively, be directed under a variety of imaging modalities,including ultrasound, fluoroscopy, or possibly even with tactileguidance. Mechanically coupling the various elongate deploymentcomponents to a common proximal housing can also avoid confusion overwhich component is to be moved, and which is to be maintained at a fixedposition. Hence, the invention facilitates deployment of intrafallopiancontraceptive devices in a wide variety of healthcare settings.

In a first aspect, the invention provides a contraceptive deliverysystem comprising a contraceptive device expandable from a small profileconfiguration to a large profile configuration. The contraceptive devicein the small configuration is insertable into an ostium of a fallopiantube. A first elongate body has a proximal end and a distal end with areceptacle disposed adjacent the distal end. The receptacle releasablyreceives the contraceptive device. A proximal handle is disposed at theproximal end of the first elongate body. The handle has a size and shapesuitable for gripping with a single hand. At least one actuator ismounted on the handle. The actuator is moveable by the hand while thehand grips the handle so as to expand the contraceptive device to thelarge profile configuration and affix the contraceptive device withinthe ostium of the fallopian tube.

Preferably, the contraceptive delivery system will further include asheath having a lumen that slidably receives the receptacle so thatmovement of the at least one actuator withdraws the sheath proximallyfrom the contraceptive device. This arrangement allows the healthcareprovider to maintain the position of the contraceptive device by holdingthe handle at a fixed position with the same hand that is used to movethe actuator. This leaves the other hand free to support thehysteroscope, which will often be used to optically direct thedeployment procedure.

The system will often further include means for expanding the uncoveredcontraceptive device after the sheath has been withdrawn. The expansionmeans will often be coupled to the contraceptive device and will beoperable by the actuator. Separating at least a portion of the expansionand sheath withdrawal mechanisms can help avoid resilient expansionforces from acting against the sheath, which forces might impedemovement of sheath and make it difficult to hold the contraceptivedevice accurately in position during deployment. While a variety ofexpansion means may be provided (such as inflation balloons and fluidlumens for plastically deforming a stent-like structure, or the like),the preferred expansion means comprises a second elongate body whichmoves relative to the first elongate body to effect expansion of thecontraceptive device after the sheath is withdrawn. In the exemplaryembodiment, the first and second elongate bodies restrain a resilientouter helical coil of the contraceptive device by maintaining a torqueuntil the at least one actuator moves a second elongate body.

In some embodiments, a first movement of a dual-function actuatorrelative to the handle moves the sheath relative to the first elongatebody without moving the second elongate body relative to the firstelongate body. A second movement of the dual-function actuator after thefirst movement moves the second elongate body relative to the firstelongate body. Optionally, a latch may releasably restrain movement ofthe second elongate body relative to the first elongate body. As thefirst elongate body will often releasably hold the contraceptive device,this can keep the device at the target location during at least a partof the deployment procedure. The first elongate body may threadinglyengage the contraceptive device, and may be decoupled from thecontraceptive device by rotating the handle or a decoupling actuator.

In another aspect, the invention provides a contraceptive deliverysystem comprising a contraceptive device which is expandable from asmall profile configuration to a large profile configuration. Thecontraceptive device in the small configuration is insertable into anostium of a fallopian tube. A first elongate body has a proximal end anda distal end. A receptacle is disposed adjacent the distal end of thefirst elongate body. The receptacle releasably receives thecontraceptive device. A sheath has a lumen which slidably receives atleast a portion of the contraceptive device. A second elongate bodyextends proximally from the contraceptive device to a proximal end. Ahandle is disposed at the proximal end of the first elongate body. Thehandle has at least one actuator, and a first movement of the at leastone actuator withdraws the sheath proximally from the contraceptivedevice. A second movement of the least one actuator moves the secondelongate body relative to the first elongate body so as to expand thecontraceptive device to the large profile configuration.

In yet another aspect, the invention provides a medical devicecomprising an elongate guiding structure having a proximal end and adistal end. The guiding structure is laterally flexible and increases inflexibility toward the distal end so that the guiding structure issuitable for distally tracking a body lumen. A proximal handle isaffixed adjacent the proximal end of the guiding structure. The handlehas a slot that laterally receives the guiding structure adjacent thedistal end. A detent is capable of restraining the guiding structurewithin the slot to facilitate introducing the distal portion into alumen.

In a method aspect, the invention comprises inserting a contraceptivedevice transcervically into an ostium of a fallopian tube by gripping ahandle with a hand of a healthcare worker and moving the hand. Thehandle is coupled to the contraceptive device by an elongate body. Theinserted contraceptive device is expanded by moving an actuator on thehandle while the hand grips the handle. The expanded contraceptivedevice is detached from the elongate body so that the contraceptivedevice inhibits conception.

Generally, a hysteroscope is manipulated by another hand of thehealthcare worker to orient the contraceptive device toward the ostiumwhile the healthcare worker views an image of the ostium with thehysteroscope. This allows the healthcare worker to simultaneouslymanipulate these two components of the contraceptive delivery system,avoiding complex coordination between two individuals.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the uterine and tubal anatomy for deployment of thecontraceptive devices of the present invention.

FIG. 1A schematically illustrates method steps for an exemplarycontraceptive device deployment method.

FIG. 1B is a partial cut-away side view of a contraceptive systemaccording to the principles of the present invention.

FIG. 2 is a side view of a removable core wire of the contraceptivesystem of FIG. 1B.

FIG. 3 is a contraceptive device of the contraceptive system of FIG. 1B,in which an outer helical coil is in a large profile configuration.

FIG. 3A is an end view of the contraceptive device of FIG. 3.

FIG. 3B illustrates a contraceptive device having a tubular band forsmoothly disengaging a release pin of a release catheter.

FIG. 4 is a side cross-section of a distal end of a delivery catheter ofthe contraceptive system of FIG. 1B.

FIG. 4A is an axial cross-sectional view of the delivery catheter ofFIG. 4.

FIG. 5 is a side cross-sectional view of an outer sheath of the deliverysystem of FIG. 1B.

FIGS. 5A-5F illustrate sheaths having positioning surfaces for axiallypositioning the contraceptive device relative to the tubal ostium.

FIG. 6 is a partial cut-away view showing engagement between the outerhelical coil of the contraceptive device and the release catheter so asto maintain the wind-down torque on the outer helical coil.

FIG. 7 is a perspective view of the proximal handle of the contraceptivesystem of FIG. 1B.

FIGS. 8A and 8B illustrate a syringe-like handle for use with thecontraceptive system of FIG. 1B.

FIGS. 9A and 9B illustrate a further alternative pistol grip handle foruse with the contraceptive system of FIG. 1B.

FIG. 10 is a perspective view of a preferred proximal handle of thecontraceptive system of FIG. 1B having a thumb wheel, latch, androtation knob for exposing, expanding, and releasing the contraceptivedevice at the target location.

FIG. 11 is a perspective view of an alternative in-line slider handlefor use with the contraceptive system of FIG. 1B.

FIGS. 11A through 11K schematically illustrate a method for deploying acontraceptive device using the system of FIG. 1B.

FIGS. 12A and 12B are side and axial end views schematicallyillustrating the use of an indentation in the handle to facilitateintroducing the guidewire-like distal end of the contraceptive deliverysystem into a lumen, such as the working lumen of a hysteroscope.

FIG. 13 illustrates an alternative deployment method using analternative imaging system.

FIGS. 14A and 14B illustrate a deployment system having a sleevedisposed around the outer sheath, and use of the sleeve to inhibitinadvertent movement of the contraceptive device when the outer sheathis retracted.

FIG. 15 schematically illustrates a side view of alternative distalcomponents for a contraceptive system.

FIG. 16 illustrates an alternative coupling structure at a proximal endof an outer helical coil used in the alternative contraceptive system ofFIG. 10.

FIG. 17 schematically illustrates a contraceptive system having aseparate positioning catheter slidably disposed over the sheath, thepositioning catheter having a positioning surface to assist in axiallypositioning of the contraceptive device.

FIG. 18 illustrates a method for using the positioning surface of asheath or positioning catheter to assist in axially positioning of thecontraceptive device.

FIG. 19 schematically illustrates a side view of a contraceptive system,showing axially coupling of the positioning catheter to thecontraceptive device.

FIG. 20 schematically illustrates a lateral cross-section of analternative outer sheath of the delivery system of FIG. 1B.

FIG. 21 schematically illustrates an alternative proximal handle of thecontraceptive system.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The present invention provides a contraceptive device, system, andmethod which can be used to inhibit pregnancy, typically for thelong-term inhibition of pregnancy, and often providing permanentcontraception or sterilization. By introducing at least a portion ofthese contraceptive devices into an ostium of a fallopian tube, therisks of unplanned expulsion, pelvic pain, and infectious complicationsmay be significantly reduced. Although the present invention may beincluded within a group of contraceptive techniques generally referredto as fallopian tube occlusion methods, the invention need not beadvanced fully into the fallopian tube, and in some embodiments, neednot fully block the tubal lumen to effectively disrupt fertilization. Asdescribed in co-pending International Patent Application No. 99/15116,assigned to the present assignee (the full disclosure of which isincorporated herein by reference), contraception may optionally beprovided by fully occluding the tubal lumen, and/or by sufficientlydisrupting the fertilization process without total occlusion. In someembodiments, including a bioactive material such as copper may enhancethe devices effectiveness.

As used herein, a structure is inserted “within a tubal ostium” wheneverthe structure is advanced from the uterus into (and optionally beyond)the tubal ostium into the uterotubal junction and/or the fallopiantubes.

Referring now to FIG. 1, access to uterus U will generally be gainedthrough cervix C. From within uterus U, fallopian tubes F are accessedvia tubal ostiums O.

Fallopian tubes F generally include three segments between ostium O andthe fimbria FIM. Beginning adjacent uterus U, the intramural segment INTof fallopian tubes F are surrounded by the muscular uterine tissues.Beginning at uterotubal junction UTJ, fallopian tubes F extend beyondthe uterine tissues and within the peritoneal cavity along an isthmicsegment ISC, and then along an ampullary segment AMP.

In general, the ideal placement for the intrafallopian contraceptivedevices of the present invention is spanning the intramural INT toisthmic ISC portion of the fallopian tube. Where a radially expandableattachment mechanism such as an outer coil is included on theintrafallopian contraceptive device, that expandable or anchoringstructure will preferably span the uterotubal junction UTJ. It should benoted that the uterotubal junction UTJ may be defined as the plane wherethe fallopian tube meets the peritoneal cavity. It should also be notedthat the narrowest portion of the fallopian tube need not necessarily bedisposed in the isthmic segment ISC, particularly once the contraceptivefallopian device (often having a radially expandable anchoringstructure) is deployed therein. In fact, work in connection with thepresent invention has shown that the effectively narrowest portion ofthe tube may be at or adjacent the uterotubal junction UTJ.

Referring now to FIG. 1A, an overview of an exemplary method 2 fordeploying and using the contraceptive devices of the present inventionis helpful to understand the selection of structures used in thosedevices. It should be understood that not all steps need be performed inevery deployment. Nonetheless, reviewing the exemplary deployment method2 will help to understand the structures described hereinbelow.

Identification of the anatomy and target location 3 allows the operatorto determine the preferred placement of the contraceptive device withinthe ostium, and also to determine if any special circumstances arepresent for a particular device placement procedure. Anatomy and targetlocation identification can be facilitated using a variety of knownvisualization modes, including hysteroscopy, sonography (ultrasound),fluoroscopy, and the like. Hence, an exemplary contraceptive device maybe adapted to delivery using more than one imaging modality.

The exemplary contraceptive device will also preferably be able toaccommodate a wide variety of anatomies. Two factors contribute to theimportance of this variability: First, a wide variation may be observedbetween tubal anatomies of differing patients. Secondly, it can be quitedifficult to determine and identify the specific tubal anatomy of aparticular patient. As a result, the preferred contraceptive device mayincorporate safeguards allowing sufficiently accurate placement (withtolerance for normal operator error), as well as for the variance in thelength and diameter of the various segments of the fallopian tube.

Exemplary deployment method 2 in FIG. 1A will also include positioningof the device at the target location 4. Once again, a wide variety oftechniques might be used to assist a healthcare professional inpositioning the device in the correct location, including visualizationtechniques, providing high-contrast markers (such as radiopaque markers,echogenic markers, or the like), providing tactile indication of theplacement position by including physical stops or “bumpers” (which maybe adapted to engage reference tissues in such a tactile way as to senda signal to the healthcare professional), or the like. Devicepositioning can be significantly facilitated by providing an appropriatedevice and/or deployment system design having the proper flexibility,navigation characteristics, friction reduction surfaces, small deliveryprofile, coatings, and the like. Once again, device positioning 4 willpreferably compensate for anatomical variations, operator error, anddifficulties in visualization so as to help promote accurate placement.

In the exemplary deployment method 2, the device is deployed and/orexpanded at the target location in the step indicated by referencenumeral 5. Optionally, the device and/or deployment system may allowvisualization and/or confirmation of device expansion while expansiontakes place.

Generally, the contraceptive device will be detached from its deploymentsystem at the target location in step 6. Once again, it is helpful toprovide visualization and/or confirmation of detachment, which may beprovided visually, via ultrasound, fluoroscopy, or the like. It shouldbe understood that a wide variety of detachment mechanisms might be usedto decouple the device from the deployment system.

In the exemplary method, it should be possible to confirm the positionof the device at the target location 7. Confirmation may be provided,once again, by visualizing at least a portion of the device afterdetachment, often using the same visualization modality used duringplacement. In addition to optical visualization techniques, this may beprovided by including radiopaque markers for fluoroscopic placementconfirmation, sonographic markers for ultrasound placement confirmation,or the like. Optionally, specific marker locations may be provided alongthe contraceptive device 2, for example, to indicate the specificlocations of proximal and/or distal ends of the device.

Exemplary method 2 further includes a step 9 for anchoring and stabilityof the device at the target location. Aspects of this step includeaccommodating visualization of the device so as to monitor it'sstability. Anchoring of the device at the target location may includeanchoring on an acute basis (such as using an expanded helical coil thatcan adjust and adapt to variations in the tubal lumen, an expandedstent-like structure, expanded braid, or the like) and long-term (suchas may be provided by including a fiber mesh or lattice which incites atissue reaction such as ingrowth, thereby providing fibrous tissueswhich affix the device in place within the fallopian tube). Similarly,stability will preferably be provided for both a short-term and along-term, typically by designing a device with the proper resiliencyand shape to accommodate physiological movement without shifting. Thedevice will preferably be wear-profile balanced to provide sufficientanchoring without inducing pain or losing its stability due to erosionfor the life of the patient.

The final step indicated on the exemplary method 2 of FIG. 1A isefficacy. This may be provided by incorporating a lumen/space fillingdesign that sufficiently alters the function and architecture of thefallopian tube so as to inhibit conception. This may include the use ofpolyester fibers to incite the desired tissue reaction.

In general, the devices of the present invention may be adapted toincite a reaction tissue response in the fallopian tube through thepresence polyester fibers, or the like. Ideally, this reaction can beclassified as a highly localized, benign tissue reaction. The reactionresults in the incorporation of the contraceptive device into the tuballumen tissues, so that the device is firmly embedded into thesurrounding tissue structure. This reaction can typically becharacterized by the proliferation of smooth muscle cells and associatedfibrosis. Additionally, the tubal lumen will generally exhibit anabsence of the normal tubal architecture which is generally necessaryfor conception. The tubal lumen may also be obstructed, occluded, and/orfunctionally occluded by the presence of the device and associatedfibrosis sufficiently to inhibit conception. The reaction is a benignone, and there appears to be no change in anatomy or structure of theouter tubal wall beyond approximately 5 to 10 mm radially outwardly fromthe outer coil of the device. Similarly, normal tubal architecture willoften be visible about 5 mm axially beyond the device (typically distalof the device, as the device often extends into the uterus), againindicating a very localized reaction.

Referring now to FIG. 1B, an exemplary contraceptive system 10 generallyincludes a contraceptive device 12, a sheath 14 partially surroundingthe contraceptive device, a release catheter 16, and a core shaft 18.Contraceptive device 12 generally has a proximal portion 20 adjacent aproximal end 22 (disposed within sheath 14), and a distal portion 24adjacent a distal end 26 (which are exposed beyond the distal end ofsheath 14). Distal portion 24 generally functions as a distal guidewirewhile system 10 is advanced within the tubal ostium. Proximal portion 20includes a radially expandable structure which can be expanded aftersheath 14 is withdrawn so as to affix the contraceptive device in thedeployed position.

Sheath 14 is generally a tubular structure having a distal end 28 andextending proximally to a proximal handle 30. Sheath 14 will generallyhave a length in a range from about 25 to about 50 cm, and willtypically have an outer diameter in a range from about 0.020 to about0.060 inches, the exemplary sheath having a length of about 39.5 cm andan outer diameter of about 0.04 inches. The inner diameter of sheath 14may be in a range from about 0.02 inches to about 0.05 inches, with theexemplary sheath having an inner diameter of about 0.33 inches.

Release catheter 16 generally comprises a tube having a distal end 34which releasably engages contraceptive device 12, and a proximal endcoupled to housing 30 via actuator 33.

In the exemplary embodiment, core shaft 18 comprises a resilienttapering structure extending from within distal portion 24 ofcontraceptive device 12 proximally to handle 30. Core shaft 18threadably engages contraceptive device 12 proximally of distal end 28of sheath 14. In the exemplary embodiment, core shaft 18 and releasecatheter 16 transmit a wind-down torque onto an expandable structure ofthe contraceptive device so as to maintain the expandable structure inthe small profile configuration. Hence, releasing core shaft 18 relativeto release catheter 16 allows the expandable structure to be activatedindependently of movement of the surrounding sheath.

Handle 30 includes a housing 31 having a size and shape suitable forgripping with a single hand. A thumb wheel actuator 33 performs twoactuation functions: first, rotation of the thumb wheel relative tohousing 31 draws sheath 14 proximally by engagement between pinion 35(attached to the thumb wheel) and rack 37 (attached to sheath 14).During this initial movement, release catheter 16 is restrained relativeto housing 31 by latch 39. Once the proximal end of rack 37 engages acooperating surface attached to release catheter 16, latch 39 can beactuated to allow release catheter 16 to move relative to the housing asthe thumb wheel 33 is again turned in the direction shown. In someembodiments, spring 51 may be compressed by rotation of the thumb wheelprior to actuation of latch 39, so that actuation of the latch slidesthe release catheter so as to disengage the release catheter fromcontraceptive device 12. In this embodiment, a proximal end of coreshaft 18 is affixed to the housing so that the core shaft is rotated byrotating the entire housing.

Components of housing 31 and actuators 33, 39, will generally comprisepolymers, metals, or the like. The actuator mechanism may include moldedand/or machined parts, and may be permanently attached to sheath 14,release catheter 16, core shaft 18, and the like so that the remainingcomponents of the delivery system 10 are disposed of once contraceptivedevice 12 has been deployed. Alternatively, it may be possible toprovide sterilizable, reusable, and/or responsible delivery systemcomponents if desired.

In the exemplary embodiment, housing 31 has an overall length in a rangefrom about 2 to about 8 inches, ideally having a length of about 7.5inches. The exemplary embodiment of rack 37 has a length of about 5.5 cmand a total travel stroke of about 4.0 cm. Release catheter 16 has astroke of about 1 cm, and movement of the release catheter relative tocore shaft 18 is inhibited prior to actuation of latch 39. Unthreadingof core shaft 18 from device 12 will typically be complete in about 10rotations or less, ideally being unthreaded with from about one quarterto about 2 full rotations of the handle (or other rotational mechanism).

While exemplary contraceptive device 12 makes use of a radiallyexpandable helical coil to help restrain the structure during tissueingrowth, a wide variety of mechanical and other restraint mechanismsmight be included. For example, alternative mechanical anchors might beattached to the device, such as resilient coils biased to form bends,loops, and/or other secondary shapes having enhanced cross-sections,slotted tubes, Malecot-type structures, radially expandable braids,stent-like devices, and the like. The mechanical structures may beresilient, plastically deformable, or the like, and suitable structuresare described in more detail in, for example, PCT Publication No. WO99/15116.

Still further device-restraint techniques might be employed, includingthermal, chemical, adhesive, and the like. These techniques can be usedto avoid expulsion by increasing friction between the device and thesurrounding tissues, by imposing limited tissue damage to promote scartissue formation, and/or by promoting tissue ingrowth into the device.Thermal techniques may include, for example, transmission of electricalor laser energy along contraceptive system 10. Resistive heating ofcontraceptive device 10 might be effected by applying an electricalpotential across the device with conductors extending along sheath 14and release catheter 16, laser energy along an optical wave guideattached to core wire 18, or the like. Monopolar tissue desiccationmight be effected via a large return electrode patch by energizing corewire 18 with radiofrequency energy, or an adhesive and/or caustic agent(such as a cyanoacrylate or silver nitrate) might be introduced via anyof the lumens of the delivery system, via a dedicated lumen orstructure, or the like. Biodegradable plugs and the like might also beincluded, and the retained structure may optionally comprise copper orother bioactive agents to help inhibit conception.

Tissue reaction to the retained contraceptive device 12 can help toprovide long term contraception and/or sterilization. To promoteconception inhibiting tissue reaction, device 12 will often include atissue reaction material, the material often comprising fibers. Thefibers may comprise a polyester, such as Dacron® polyesters, silk,nylon, or the like. The fibers may be in the form of a weave, a knit, abraid, a felt, or the like, or may comprise stands attached to thedevice body.

The components of contraceptive system 10 can be further understood withreference to FIGS. 2 through 5, in which these components areillustrated individually. Beginning with FIG. 2, core shaft 18 tapers toa gradually increasing diameter proximally of distal end 40 so as toprovide increasing support of distal portion 24, proximal portion 20,and the catheter structures proximal of contraceptive device 12. Thisincreasing support (and the associated increase in column strength)enhances the pushability of the contraceptive system while accessing thetarget deployment site. Threads 42 threadingly engage a coil of thecontraceptive device, and are generally formed by affixing a coil withseparated windings to a central core wire at a bond 44. A tube 43 mayalso be affixed at bond 44 to prevent binding and/or jumping of thecooperating threads, the tube ideally comprising stainless steel,platinum, or the like. In the exemplary device, core shaft 18 comprisesa high strength metallic structure.

The exemplary contraceptive device 12 is illustrated in more detail inFIG. 3. Contraceptive device 12 includes a primary coil 50 which extendsfrom a distal ball tip 52 to proximal threads 54, which may convenientlybe formed by separating the proximal windings of the primary coil. Theexpandable structure, here in the form of a helical outer coil 56, has aproximal end bent to form a wind-down attachment 58, and has a distalend affixed to coil 50 at coil bond 60. Fiber 62 extends between theinner and outer coils, and is also disposed within primary coil 50 so asto promote tissue ingrowth throughout the cross-section of contraceptivedevice 12. The arrangement of coil attachment 58 and position of fiber62 can be seen in the axial view of FIG. 3A. By making use of acontraceptive device having a distal portion 24 which can act as aguidewire, no open lumen need be provided through the center of thecontraceptive device (for example, for a separate guidewire), andmultiple access/deployment steps (for example, accessing the targetlocation with a guidewire, advancing a catheter over the guidewire,removing the guidewire from the positioned catheter, and then advancingthe contraceptive device) can be avoided. While the exemplary systemuses threads to couple the core wire (or other deployment shaft) to thecontraceptive device, a variety of alternative detachable connectionsmight be used, including cooperating keys/slots, connectors, or thelike.

In the exemplary embodiment, coil 50 is formed of a high strengthresilient material, ideally comprising stainless steel wire having adiameter of about 0.005 inches, and wound to form a coil having an outerdiameter of about 0.022 inches. Ball tip 52 preferably has across-section which is larger than the cross-section of coil 50, theball tip generally having a diameter in a range from about 0.020 inchesto about 0.050 inches, the exemplary ball tip having a diameter of 0.027inches.

Helical coil 56 comprises a highly elastic high strength metal which isbiased to expand from the low profile configuration illustrated in FIG.1 to the larger profile configuration illustrated in FIG. 3 whenreleased within the target site. In the exemplary embodiment, outer coil56 comprises a ribbon of a superelastic shape memory alloy, and has athickness of about 0.001 inches and a width of about 0.015 inches, withthe ribbon being biased to form a helical coil having an outer diameterof about 0.080 inches and a length of about 3.5 cm when not otherwiserestrained. Outer coil 56 is preferably fixed to primary coil 50 by abond 60 of solder. Bond 60 will preferably be separated from ball tip 52by a distance in a range from about 0.3 cm to about 1.0 cm.Advantageously, bond 60 may be aligned with the distal end 28 of sheath14 so as to help present an atraumatic increase in diameter betweendistal portion 24 of contraceptive device 12 and the sheathed proximalportion 20 prior to deployment.

Fiber 62 may comprise a polyester, or the like. The fiber may be looselywoven or matted strands, with at least one end of the fibers affixed toprimary coil 50 or outer coil 56.

Generally, the expandable structure will at least help holdcontraceptive device 12 in place until tissue ingrowth occurssufficiently so as to permanently retain the contraceptive device.Hence, the expandable structure will often benefit from a relativelyhigh friction outer surface. Such an outer surface might make itdifficult to advance the contraceptive device into position if thedevice is advanced without sheath 14.

Work in connection with the present invention has shown that resilientlyexpandable structures which have sufficient strength to reliably holdthe contraceptive device within the ostium of the fallopian tube mayimpose significant frictional forces against a surrounding sheath. Thesefrictional forces can significantly complicate the accurate delivery ofcontraceptive device. Hence, outer coil 56 is preferably maintained in asmall profile configuration within sheath 14 by applying a wind-downtorque between core wire 18 and release catheter 16. The core wire cantransfer the wind-down torque to outer coil 16 through cooperatingthreads 42, 54, with the direction of the wind-down torque preferablybeing arranged so that the wind-down torque discourages decoupling ofthe threads. In other words, rotation of core wire 18 relative tocontraceptive device 12 in a direction opposed to the wind-down torqueis used to detach core wire 18 from contraceptive device 12.

A slight variation upon the wind-down attachment is illustrated in FIG.3B. An alternative contraceptive device 12 a includes a small tube orband 59 soldered within a small diameter proximal section of the outercoil 56. Band 59 can have a relatively large interface area with coil 56to facilitate bonding. Use of the band helps avoid stressconcentrations, and also presents a smooth inner lumen which may inhibitbinding of the release catheter. Band 59 may comprise stainless orplatinum, ideally having an inner diameter of about 0.023 inches and anouter diameter, with a thickness of the surrounding outer coil andsolder bond, of about 0.030 inches. A similar band 59′ may be disposedwithin threads 54 of coil 50 to provide a radiopaque marker, and toinhibit thread jump. Band 59′ may be similar in structure to band 59,but shorter in length. Still further alternative attachment mechanismsare possible. For example, a mass or knob may be formed at the proximalend of outer coil 56 from a simple ball of solder, coil material, bend,or the like. This mass may be slidably receivable within slot of thedelivery catheter.

The distal structure of release catheter 16 is shown in FIGS. 4 and 4A.The wind-down torque is releasably transferred between outer coil 56 andrelease catheter 16 by cooperation between bend 58 and pin 66 at thedistal end 34 of the release catheter 16. Release catheter 16 generallyincludes a tubular body 68 formed of rigid polymers such as polyimide.Pin 66 is disposed within a lumen of tubular body 68, and is supportedwithin the tubular body by a helical support coil 70 and adhesive 72.Interestingly, the tubular body dimensions may be driven by thewind-down torque transferred proximally by release catheter 16.

The structure of sheath 14 is illustrated in more detail in FIG. 5.Distal end 28 (see FIG. 5A) of sheath 14 will preferably be rounded,with the distal end ideally cooperating with coil bond 60 ofcontraceptive device 12 so as to avoid friction and facilitate distalnavigation of delivery system 16 through the uterotubal junction andinto the fallopian tube. The rounded distal end 28 may optionally berounded along both the inner and outer diameter of sheath 14, or mayprimarily be rounded along the outer diameter so as to taper inwardlydistally.

Sheath 14 will preferably have a multi-layer structure, with the layerscomprising (beginning at the outside) a hydrophilic coating 76 to reducefriction during tracking and navigation. Such hydrophilic coatingsbecome quite slippery when exposed to fluid. Below hydrophilic coating76 is a structural layer of a polymer 78 such as Tecoflex™ along theproximal portion of sheath 14, and a reinforcing braid 80 of a metal,ideally of stainless steel, is disposed within a layer of polyimidebelow polymer layer 78. Along the more distal portion of sheath 14,metal braid 82 is disposed within polymer layer 78 of Tecoflex™, or thelike, and the polyimide layer is absent so as to provide enhancedflexibility. The inner lumen of sheath 14 is defined by a low frictionpolymer coating 84, the low friction polymer ideally comprising a PTFEsuch as Teflon®. Exemplary sheaths 14 may be commercially available froma variety of vendors. Suitable structures may be described in moredetail in published PCT patent application WO 98/57589, the fulldisclosure of which is incorporated herein by reference.

As schematically illustrated in FIGS. 5A through F, alternative sheaths14A, B, and C, include bumpers 57, 57′, and 57″, respectively. Bumper 57has an outer surface extending radially from the outer surface of theunderlying sheath. Although bumper 57 may optionally provide a tactileindication that the sheath 14A is advancing distally beyond the targetdeployment position, it does not necessarily prevent the sheath fromadvancing so that the bumper can enter into the tubal ostium. Bumper 57may also provide a visible marker that hinders pushing of the sheath sothat the bumper moves past the ostium. Optionally, bumper 57 maycomprise a colored adhesive, or may comprise a clear adhesive with acolored band of material disposed underneath.

Alternative bumpers 57′ and 57″ may comprise polymer or metallicstructures, ideally comprising a polyethylene or a super-elastic,shape-memory alloy. These radially expandable bumper structures can becollapsed for delivery through a working lumen of a hysteroscope, andcan then expand to impede advancement of the sheath by engaging theuterine tissue adjacent to the tubal ostium.

Referring now to FIG. 6, the sliding engagement between pin 66 ofrelease catheter 16 and bend 58 of outer coil 56 is more clearlyillustrated. FIG. 6 also shows how the wind-down torque imposed on theouter coil by the core shaft 18 and release catheter 16 help maintainthe outer coil in a small profile configuration within sheath 14,allowing the sheath to be withdrawn easily. The wind-down torque can bereleased by sliding release catheter 16 so that pin 66 slides free ofbend 58. Optionally, the release catheter may first be allowed to rotaterelative to the core shaft to reduce the engagement forces between bend58 and pin 66.

Referring now to FIG. 7, thumb wheel 33 and latch 39 are convenientlylocated for actuation by a thumb of a surgeon, nurse, or otherhealthcare professional while the healthcare professional grips handle30 with the remaining fingers of the hand. This allows the healthcareprofessional to perform several of the deployment steps with a singlehand. In general, movement of overall housing 31 is used to advancecontraceptive device 12 distally into the tubal ostium, and to navigatethe contraceptive delivery system within the uterotubal junction andfallopian tube. Once the contraceptive device is positioned, thumb wheel33 withdraws sheath 14 from over the contraceptive device, while housing31 continues to rotationally and axially couple the proximal ends of therelease catheter 16 and core shaft 18, thereby maintaining the wind-downtorque on the contraceptive device so as to restrain the contraceptivedevice in its small diameter configuration.

Once the proximal portion of the contraceptive device is exposed, latch39 can be depressed and thumb wheel 33 can again be turned proximally todisengage pin 66 of release catheter 16 from the wound-down outer coilof the contraceptive device, thereby radially expanding thecontraceptive device. Advantageously, prior to expansion, it may bepossible to withdraw the contraceptive device proximally back into thesheath 14 and/or slightly reposition the contraceptive device within thetubal ostium if desired.

Once the contraceptive device has been both exposed and expanded, handle30 is rotated as illustrated to threadingly disengage core shaft 18 fromthe contraceptive device 12. Hence, handle 30 allows the healthcareprofessional to position the contraceptive device, expose thecontraceptive device, actuate the contraceptive device so as to affixthe device to the surrounding tissue, and decouple the contraceptivedevice from the remaining components of the delivery system with asingle hand.

As can be understood with reference to FIGS. 8A through 11, a widevariety of alternative one-handed release handles might be used with thecontraceptive delivery system of FIG. 1B. Referring now to FIGS. 8A andB, an axial motion handle 30 a uses a syringe-type axial pull motion topull sheath 30 back with the fingers of a hand towards a palm of thehand (which is generally held at a fixed position). This effects axialmotion of sheath 14 to withdraw the sheath from over the contraceptivedevice, followed by axial motion of release catheter 16 to allow thecontraceptive device to expand. Optionally, a knob 41 may be affixed tothe proximal end of core shaft 18, so that rotation of knob 41threadingly disengages the core wire from the expanded contraceptivedevice. Knob 41 may include a releasable latch coupling the knob to thehousing to prevent rotation of the core shaft and maintain the wind-downtorque until release is desired. Advantageously, axial motion handle 30a allows for multiple hand sizes and various hand positions, andpresents a form which is familiar to doctors.

FIGS. 9A and B illustrate a still further alternative pistol grip handle30 b for effecting one-handed deployment of the contraceptive device. Inthis embodiment, a trigger actuator 43 moves sheath 14 and releasecatheter 16 via a bead chain 45 and a bead chain drive wheel and geararrangement. After actuation of the trigger actuator 43 with, forexample, and index finger of the hand, a latch button (not shown) may bedepressed and knob 41 rotated by a thumb of the hand to decouple thecontraceptive device from core shaft 18.

Referring now to FIG. 10, a preferred one-handed release handle 30 cincludes a thumb wheel 33 which, when turned relative to the surroundinghousing, initially causes movement of sheath 14 relative to core shaft18 as will be described in detail herein below. Once the contraceptivedevice has been uncovered, depressing safety latch 39 allows the thumbwheel to again be rotated so as to move release catheter 16 relative tothe core shaft to allow the contraceptive device to expand. Thesemovements of thumb wheel 33 can easily be performed while maintainingthe housing of preferred handle 30 c at a fixed location, therebyavoiding movement to the contraceptive device. Once deployment hasexposed and expanded the contraceptive device at the target location,knob 41 may be rotated, again while holding the remaining handle at afixed location. The internal mechanism providing these movements isillustrated in FIGS. 11D, 11E, 11F, and 11H.

Still further alternative one-handed release handles may be provided,including an in-line slider handle 30 d having a thumb slide 47 forsequential movement of the sheath 14 and then release catheter 16relative to core shaft 18, as shown in FIG. 10. A knob 41 may be allowedto rotate relative to the housing by depressing a latch 39, or theentire housing may be rotated to detach the engagement threads, asdescribed above.

An exemplary method for use of contraceptive system 10 can be understoodwith reference to FIGS. 11A through 11K. Preferably, a healthcare workerwill manipulate contraceptive delivery system 10 with a first hand H1while supporting an imaging and/or access device such as a fluoroscopycatheter, sonography catheter, or hysteroscope S with a second hand H2.This allows the healthcare professional to personally control theorientation of distal advancement of the contraceptive system and itsmovement and deployment while viewing the procedure through the scope S(shown here schematically by eye E). While scope S is illustrated hereas a simple optical device, it should be understood that a variety ofscope structures are encompassed by the system and method of the presentinvention, including rigid optical scopes, scopes having a coherentfiber optic bundles, scopes which include charge-couple devices (CCD's)for displaying an image of the procedure in a monitor, and the like).Exemplary hysteroscopes for use with the present invention arecommercially available from Richard Wolf of Chicago, Ill. under modelname 5 MM OVAL SCOPE.

Referring now to FIG. 11B, system 10 is introduced transcervicallythrough uterus U, generally under optical direction. Using hysteroscopeS the physician directs the distal end of the system toward ostium O offallopian tube F. Uterus U may be irrigated and/or distended using scopeS and/or a separate irrigation or gas insufflation system. Once ostium Ois located and the scope S is oriented toward the ostium, system 10 isadvanced distally through the working lumen of the scope and into theostium using distal portion 24 of the contraceptive device as aguidewire, while the remainder of the contraceptive device remainscovered by sheath 14.

The outer hydrophilic coating of sheath 14 minimizes friction whileadvancing system 10, and the sheath also provides structural columnstrength to the system. The distal ball tip of distal portion 24 aidstracking and navigation through fallopian tube F, while the primary coilstructure flexes laterally to track the tortuous bends often foundwithin the fallopian tube. In the exemplary embodiment, core wire 18extends into distal portion 24 to enhance column strength of the distalportion beyond sheath 14, but does not extend to the ball tip. Hence,the stiffness of distal portion 24 increases proximally, furtherenhancing the distal portion's ability to track the lumen.

In the exemplary embodiment, sheath 14 includes a visual marker 98 whichcan be seen from the scope of hysteroscope S. Marker 98 will preferablybe positioned partially within ostium O and partially within uterus U,thereby indicating that contraceptive device 12 is disposed at thetarget position, as the sheath, core shaft, and contraceptive device arereleasably locked together during advancement and positioning an opening(as the sheath, core shaft, and contraceptive device are releasablylocked together during advancement and positioning). As described above,marker 98 may comprise a bumper, a structure which extends radially fromthe sheath to provide a tactile positioning indication.

Preferred positioning of contraceptive device 12 is illustrated in FIG.11C. Preferably, device 12 extends across the uterotubal junction UTJ,with the device ideally extending both proximally and distally of theuterotubal junction. The intermural section INT (see FIG. 1) typicallyhas a length in a range from about 1 to about 2 cm, and outer coil 56will preferably extend proximally beyond ostium O into uterus U by adistance in a range from about 0.2 to about 1.2 cm. Outer coil 56 willpreferably extend distally of the intermural section INT and/oruterotubal junction UTJ by a distance of at least about 0.6 cm. As theuterotubal junction UTJ is adjacent muscular tissues which are softenhigher in strength than the delicate tubal tissues of the more distalsections of fallopian tube F, the narrowest portion of the fallopiantube (particularly after deployment of device 12) will often be foundadjacent the uterotubal junction. Extending the expandable structureboth distally and proximally of this narrowing can provide anchoringagainst proximal and distal movement of the device, thereby avoidingmovement of contraceptive device 12 from the target position whiletissue ingrowth takes place. Advantageously, positioning accuracy with arange of about 1 cm may be provided by limiting marker 98 to a 1 cmlength. This provides a sufficient positional tolerance for ease of usewhile helping to ensure reliable, well-anchored deployments.

Referring now to FIGS. 11C, 11D, and 1B, positioned contraceptive device12 is deployed by first withdrawing sheath 14 from over the expandablestructure. Using the embodiment of FIG. 10, thumb wheel 33 is rotatedproximally by thumb TH to draw sheath 14 proximally from over thecontraceptive device. Handle 30 is held in a fixed position, while thethumb wheel is rotated, so that core shaft 18 maintains contraceptivedevice 12 at the target location within the tubal ostium. Once rack 37engages the corresponding proximal structure of release catheter 16,further movement of sheath 14 and thumb wheel 33 will be impeded untillatch 39 is depressed, as can be understood with reference to FIG. 11B.At this time, device 12 has been positioned at the target location, andsheath 14 has been withdrawn proximally allowing the proximal portion ofthe contraceptive device to be viewed from Scope so as to verify initialpositioning.

Referring now to FIGS. 11F, 11G, and 11H latch 39 is depressed so as toallow the proximal structure of release catheter 16 to be moved axiallyby rack 37. After latch 39 is depressed, thumb wheel 33 can again berotated so as to draw both sheath 14 and release catheter 16 proximallyrelative to core shaft 18. As seen in FIG. 11H and described above withreference to FIG. 6, this rotationally decouples the outer coil of thecontraceptive device from the release catheter 16, allowing the releasecatheter to expand.

While the dual action thumb wheel and safety latch mechanism illustratedin FIGS. 11F and 11G is preferred, a variety of alternativeuncovering/expansion mechanisms may be employed. For example, referringagain to FIG. 1B, spring 51 hinders rotation of thumb wheel 33 untillatch 39 is depressed. Optionally, spring 51 may store sufficient energyto move release catheter 16 relative to core shaft 18 when latch 39 isactuated, or spring 51 may be entirely absent so that latch 39 allowsthe thumb wheel to expand the expansible structure by moving both sheath14 and release catheter 16 relative to the core shaft 18.

Once core shaft 14 has been withdrawn from over the expandable structureand release catheter 16 has been disengaged from the exposed expandablestructure resiliently expands and affixes contraceptive device in place,handle 30 may be rotated to disengage the contraceptive device 12 fromthe remaining components of delivery system 10. Referring once again toFIGS. 11F and 11G, sliding proximal structure 16 a attached to proximalend of release catheter 16 proximally allows a proximal structure 18 aof core shaft 18 to rotate. More specifically, splines on the proximalstructure of the release catheter are moved axially beyond cooperatingsplines on the proximal structure of the core shaft. The core shaftproximal structure 18 a is rotationally coupled to knob 41, so that thecooperating splines prevent rotation of the knob prior to thedeployment's stroke of the release catheter, but thereafter allow theknob to be rotated so as to facilitate decoupling of core shaft 18 fromthe contraceptive device.

Referring now to FIGS. 11I, 11J, and 11K, once the proximal structuresof the release catheter and core shaft 16 a and 18 a have moved so thatknob 41 is free to rotate, the operator rotates the knob using thumb THand/or the fingers of the hand holding release handle 30C. As describedabove, the direction of rotation of the core shaft for disengagementwill be generally opposed to that imposed by the wind-down torque, sothat the wind-down torque helps maintain threaded engagement. Once coreshaft 18 is unthreaded from contraceptive device 12, handle 30, sheath14, release catheter 16, and core shaft 18 may be withdrawn proximallyinto and/or through the scope S. Scope S may be remain within uterus Uand another delivery system may be inserted into the scope fordeployment of a contraceptive device in the ostium of the opposedfallopian tube. After deployment of both contraceptive device in the twofallopian tubes, and after the scope is used to visually verify bothdeployments have been successful, the scope is withdrawn transcervicallyfrom the uterus, as illustrated in FIG. 11K.

Referring now to FIGS. 12A and B, a slotted handle 30 d preferablyincludes a slot 100 which laterally receives sheath 14 when the distalportion of delivery system 10 is bent as shown. As can be seen mostclearly in the view along the distal axis of the delivery system shownin FIG. 12B, slot 100 fittingly receives sheath 14 adjacent the distalend of the delivery system. Detents 102 extend from the housing intoslot 100 and restrain sheath 14 within slot 100 against the resilientstraightening forces from the sheath, from release catheter 16, and fromcore shaft 18.

The elongate components of delivery system 10 which extend distally fromhandle 30 d to the distal end of distal portion 24 present an elongateguiding structure with a lateral flexibility which increases distallytoward the distal end. By releasably securing this self-guidingstructure within slot 100, the guiding structure can be easily insertedinto a working lumen W of hysteroscope S using handle 30 d. This avoidshaving a long flexible guidewire-like structure extending in cantilevera considerable distance from the handle, or having the dead weight ofthe handle flopping uncontrollably while the delivery system is graspedadjacent the distal end of sheath 14 to insert distal portion 24 intothe working lumen. Such a structure will have a wide variety ofapplications for guidewires and guidewire-like structures havingproximal handles for facilitating insertion of their distal ends intolumens of vascular access catheters, insertion sheaths, monorailcatheter lumens, and the like.

Referring now to FIG. 13, a variety of alternative deployment methodsmight be used to deploy the contraceptive system 10. For example, usinga simple cervical catheter 102, deployment might be directedsonographically, fluorscopically, under magnetic resonance imaging, andpossibly even solely from tactile information. In the alternativeexemplary method illustrated in FIG. 13, a balloon 104 of cervicalcatheter 102 is inflated via inflation port 106. This allows the uterusU to be distended by introduction of distention media through a uterinecatheter 108 inserted through the working lumen of cervical catheter102. Preferably, anatomy and target location identification, devicepositioning, deployment, detachment, and position confirmation (asoutlined in method 2 with reference to FIG. 1A) is performed under theguidance of ultrasound and/or fluoroscopic imaging. Relevant uterinecatheter manipulation structures and methods are described in U.S. Pat.Nos. 5,346,498; and 5,389,100, the full disclosure of which areincorporated herein by reference.

As described above, the delivery systems of the present invention willoften hold the contraceptive device in a fixed position while thecontraceptive device is uncovered, expanded, and/or released. Whenmoving, for example, outer sheath 14 so as to expose the proximalportion of the contraceptive device, friction between the outer sheathand the surrounding hysteroscope (or other introducing structure,surrounding tissue, or the like) may cause inadvertent movement of thecontraceptive device. To avoid such inadvertent movement, an outersleeve may be slidably disposed around outer sheath 14. The sleeveprovides a sliding interface between the sheath and surroundingstructures. By axially coupling the sleeve and core shaft 18, frictionbetween the sleeve and surrounding structures may inhibit movement ofthe contraceptive device.

Referring now to FIGS. 14A and 14B, a sleeve 112 is slidably disposedaround at lease a proximal portion of sheath 14. Sleeve 112 is axiallyrestrained relative to core shaft 18 by axially connecting the proximalend of the sleeve to housing 110 of handle 30 c′, optionally using arotatable connector 114 (to allow the sleeve to rotate relative to thehousing). Sleeve 112 will often have a distal end disposed proximally ofcontraceptive device 12.

As can be seen in FIG. 14B, sleeve 112 will often advance into a sealingintroducer structure such as a nipple value V of hysteroscope S. Sleeve112 may also extend at least through the bend where a working lumen WLof the hysteroscope joins the main shaft of the scope. Sleeve 112 allowsindependent movement of sheath 14 despite frictional engagement betweenthe sleeve and nipple valve V, and between the sleeve and working lumenWL. Rotatable connector 114 allows free rotation of handle 30 c′ (andcore shaft 18) during disengagement of the core shaft from thecontraceptive device.

Referring now to FIGS. 15 and 16, an alternative contraceptive system150 includes a contraceptive device 152 having many of the componentsdescribed above, but having an alternative wind-down outer coilconnector 154 disposed at a proximal end of outer coil 56. Analternative release catheter 158 having a corresponding connector 160for engagement with connector 154 of contraceptive device 152 againallows a wind-down torque to be releasably maintained, as describedabove. In this embodiment, wind-down connector 160 of release catheter158 comprises an opening which receives a protrusion 162 extendingradially from a tubular band of connector 154. These alternativeconnectors, as well as further alternative threaded connectors 170, 172for releasable engagement between the primary coil and core wire, aremore fully described in an application entitled “Insertion/DeploymentCatheter System for Intrafallopian Contraception” (previouslyincorporated herein by reference), which is filed concurrently herewith.One or more of these connector structures will preferably provide a highcontrast image under at least one known medical imaging modality. Suchmarkers can help positioning of contraceptive device 150, and/orverification of disengagement between corresponding connectors(particularly when each of the engaging connectors in a connector pairprovides a high imaging contrast).

Referring now to FIGS. 17 and 18, positioning surface 57 may optionallybe affixed to sheath 14 to help axially position contraceptive device152 across intermural region INT, as described above. Engagement betweenradially protruding positioning surface 57 and the uterine tissuesurrounding ostium O facilitates initial axial positioning by takingadvantage of the axial coupling of sheath 14 to the contraceptivedevice. However, sheath 14 will often be withdrawn proximally into scopeS early-on during deployment, and it is often desirable to maintain theaxial position of the contraceptive device at least until proximal coil56 begins to expand radially.

As schematically illustrated in FIG. 17, by affixing axial positioningsurface 57 (which may optionally comprise any of the alternativepositioning surface configurations described hereinabove, or stillfurther alternative structures) at a distal end of a separatepositioning catheter 184 slidably disposed over sheath 14, the axialpositioning provided by the positioning surface may be maintained duringand/or after withdrawal of sheath 14.

Referring now to FIGS. 17 and 19, a proximal portion 186 of positioningcatheter 184 may be axially coupled to a distal portion of handle 30.This arrangement is fairly easy to manufacture, and effectively axiallycouples contraceptive device 152 to positioning surface 57 via handle30. Alternatively, positioning catheter 184 may be axially coupled tothe release catheter within sheath 14, or to any of the other axiallyelongate delivery system components extending distally from the handle.

Note that if positioning surface 57 extends distally of the proximal endof outer coil 56, it is possible that the proximal portion of the outercoil will expand partially in the positioning catheter, particularlywhere the positioning catheter is affixed axially to handle 30 andhandle 30 is affixed axially to the core wire. Axial coupling of thepositioning catheter to the release catheter (rather than the core wire)may allow at least partial withdrawal of the positioning catheter priorto expansion of the outer coil. In some embodiments, a distal portion ofpositioning catheter 184, positioning surface 57, and/or a proximalportion of outer coil 56 may be adapted so as to facilitate proximalwithdrawal of the positioning catheter after the outer coil hasexpanded, such as by limiting a diameter of a proximal portion of theouter coil, providing a low friction surface along an inner lumen of therelease catheter and/or along the outer surface of the proximal portionof the outer coil, or the like. Fortunately, the relatively highfriction outer surface of the distal portion of outer coil 56 within theostium of the fallopian tube will help inhibit axial movement of thecontraceptive device after sheath 14 is withdrawn proximally.

Referring now to FIG. 20, an alternative outer sheath 214 may be used inplace of outer sheath 14 in the system of FIG. 1B. Sheath 214 has aproximal portion 216 with a relatively stiff, thicker-walled tubularstructure, such as a PeBax® polymer tube having an outer diameter ofabout 0.062″, and an inner diameter of about 0.042″. A distal portion ofsheath 14 includes an inner tube 218 of a low friction polymer and anouter tube 220 of a polymer, (such as Carbothane™ 73A) with at least oneribbon coil 222 therebetween.

Inner tube 218 may comprise a PTFE (such as a Teflon® material) with aninner diameter of about 0.034″ and a wall thickness of about 0.001″ withthe outer diameter etched, and a length of about 5.0 cm, while there arepreferably two counterwound ribbon coils 222 of a superelastic or shapememory alloy, such as nickel titanium (optionally with chromium) ofabout 0.007″ by about 0.010″ with a pitch of about 0.015″ and a lengthof about 4.0 cm. Inner tube 218 might alternatively comprise ETFE, gammastable PTFE, FEP, or the like, while ribbon coils 222 may comprise astainless steel or other medical grade materials. An inner diameter ofthe distal portion may be about 0.034″, with the distal outer diameterof sheath 214 being about 0.041″. An intermediate outer tube 224 maycomprise a polyurethane having a durometer of about 55. A length ofouter tube 220 may be about 1.0 cm, a length of intermediate tube 224may be about 5 mm, and a length of proximal portion 216 may be about 40cm.

Referring now to FIG. 21, a still further alternative proximal handle230 includes many of the axial movement components of handle 30 c, asdescribed above. Rather than providing a rotatable knob 41, detachmentof the contraceptive device from the core wire 18 of the delivery systemmay be effected by rotation of handle 230 about the axis of thecorewire. Still further options are possible, including the detachmentof a distal portion of the corewire from the proximal portion, so thatthe distal portion remains within the contraceptive device afterdeployment.

While the exemplary embodiment of the present invention has beendescribed in some detail, for clarity of understanding and by way ofexample, a variety of adaptations, changes, and modifications will beobvious to those who are skilled in the art. Hence, the scope of thepresent invention is limited solely by the independent claims.

1-39. (canceled)
 40. A contraceptive delivery system comprising: acontraceptive device insertable into a female reproductive organ, thecontraceptive device having an inner portion and an outer portionsurrounding the inner portion, wherein the outer portion is expandablefrom a small profile configuration to a large profile configuration; arelease catheter having a proximal end, a distal end and a lumenextending therethrough, wherein the distal end of the release catheterreleasably engages the contraceptive device; a core shaft extendingthrough the lumen of the release catheter, the core shaft beingreleasably coupled to the contraceptive device; a handle connected witha proximal end of the core shaft, the handle having a size and shapesuitable for gripping with a hand; a first actuator mounted on thehandle, wherein movement of the first actuator by hand causes thecontraceptive device to expand and affix to the female reproductiveorgan; and a second actuator mounted on the handle, wherein movement ofthe second actuator by hand causes the contraceptive device to bedecoupled from core shaft.
 41. The contraceptive delivery system ofclaim 40, wherein rotation of the first actuator causes thecontraceptive device to expand and affix to the female reproductiveorgan.
 42. The contraceptive delivery system of claim 41, wherein thefirst actuator comprises a thumb wheel.
 43. The contraceptive deliverysystem of claim 40, wherein rotation of the second actuator releases thecontraceptive device from the core shaft.
 44. The contraceptive deliverysystem of claim 43, wherein the second actuator comprises a rotatableknob.
 45. The contraceptive delivery system of claim 40, wherein theouter portion is fixed to the inner portion with a bond.
 46. Thecontraceptive delivery system of claim 40, wherein the bond is a solderbond.
 47. The contraceptive delivery system of claim 45, wherein thecontraceptive device further comprises a flexible distal portionextending distally from the bond to aid in tracking of the contraceptivedelivery system in the female reproductive organ.
 48. The contraceptivedelivery system of claim 47, wherein the contraceptive device furthercomprises a distal ball tip at a distal end of the flexible distalportion.
 49. The contraceptive delivery system of claim 48, wherein thedistal ball tip has a diameter in a range from about 0.020 inches toabout 0.050 inches.
 50. The contraceptive delivery system of claim 47,wherein the bond is separated from the distal ball tip by a distance inthe range from about 0.3 cm to about 1.0 cm.
 51. The contraceptivedelivery system of claim 47, wherein the flexible distal portioncomprises stainless steel wire.
 52. The contraceptive delivery system ofclaim 51, wherein the stainless steel wire has a diameter of about 0.005inches.
 53. The contraceptive delivery system of claim 51, wherein thestainless steel wire is wound to form a coil.
 54. The contraceptivedelivery system of claim 53, wherein the coil has an outer diameter ofabout 0.022 inches.
 55. The contraceptive delivery system of claim 40,wherein the core shaft comprises stainless steel.